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510(k) Data Aggregation
K Number
K233707Device Name
HFT150
Manufacturer
Invent Medical Corporation
Date Cleared
2024-06-14
(207 days)
Product Code
BTT
Regulation Number
868.5450Why did this record match?
Applicant Name (Manufacturer) :
Invent Medical Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HFT150 is for spontaneously breathing adult and pediatric patients (10 kg and up) who would benefit from receiving high flow warmed and humidified respiratory gases. The flow may be from 2 - 60 L/min depending on the patient interface. HFT150 is used in hospital and professional healthcare environments.
Device Description
The HFT150 is a heated humidifier with integrated flow source and a heated breathing tube to deliver warmed and humidified gas flow to a patient. The HFT150 includes an integrated oxygen module, delivering an oxygen range of 21% to 100% to the patients. The HFT150 humidifier is comprised of two connected functional units. One is a motorized blower assembly that provides air flow and the delivery of supplemental oxygen to patients via an integrated oxygen module. The blower speed is directly related to total delivered flow and is controlled by software with a flow sensor. The blower assembly output connects directly to an integrated humidification tub. The second functional unit of the HFT150 is a heated humidifier. The tub is integral to the HFT150. Software monitors ambient temperature, humidity, and flow to optimize the humidity delivery to the patient and minimize condensation in the patient circuit. The HFT150 is protected from contaminants and pathogens by an integral anti-bacterial filter. The nasal cannulas, heated tubes, and water tubs are disposable and are for single use only. The HFT150 may be operated by nurses, respiratory therapists, or doctors and water tubs are disposable and are for single use only. The HFT150 may be operated by nurses, respiratory therapists, or doctors.
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